‘Point of care’ manufacturing law provides boost to UK medicines innovation

The regulations, which provide for so-called ‘point of care’ (POC) manufacturing, are expected to come into effect across the UK next summer.

POC products are typically highly innovative and often personalised in nature and have a short shelf-life, which the Medicines and Healthcare Regulatory Authority (MHRA) has previously acknowledged can be calculated in “hours, minutes or less” rather than the years that most conventional medicines last before they expire. As a result, it is generally unsuitable for POC products to be made at single manufacturing sites – rather, they need to be made in very close proximity to patients, such as within hospital settings, including in small portable units.

The new regulations provide the legal framework for such POC manufacturing to take place – as well as the control measures that are designed to ensure quality assurance. The new rules come after the MHRA previously consulted on the development of a new POC manufacturing rulebook, confirming legislation would be developed in this regard in early 2023.

The MHRA said it is “developing detailed, supporting guidance and will engage with industry, academia and healthcare institutions to ensure that the necessary interpretation and procedural support is in place to support the implementation of the new regulations ahead of the date that the legislation will come into force”.

POC manufacturing is a concept that applies to a wide range of different types of medicinal products, but it includes advanced therapy medicinal products (ATMPs) such as cell and gene therapies. Ian Turner of Pinsent Masons, a biochemist and expert in intellectual property law in the field of life sciences, said the development of a new POC manufacturing rulebook in the UK – which MHRA has claimed is the first of its kind anywhere in the world – should hopefully assist new ATMPs in being brought to market.

Turner said: “Cell and gene therapies, such as CAR-T cell therapies, hold huge potential for treating cancer and other diseases, but businesses need the confidence to invest in developing such innovative treatments. Part of that confidence is affected by the budgets of payers, like the UK NHS, and the reimbursement mechanisms they operate but they first need to be confident that the regulatory regime enables manufacturing and speedy supply to patients – both go to the heart of commercial incentives to invest.”

“There have been suggestions that restrictions over manufacturing and supply in the UK have had a bearing on some manufacturers’ decisions not to seek to launch innovative ATMPs in the UK in recent times, so developments like this new POC manufacturing rulebook are to be welcomed and may assist in encouraging manufacturers to bring ATMPs to market. The problems with the NICE approval and NHS funding regimes are well-recognised and budgets are tight – with industry no doubt eagerly anticipating the UK Budget next week – so there remains lots to do in the UK to ensure innovative medicines come to market,” he said.

Turner said that while there are challenges for businesses to navigate, there are reasons to be positive about the UK’s position as a world-leading market for innovation in life sciences.

In this regard, he highlighted the fact that the first CRISPR therapy, Casgevy, obtained marketing authorisation in a UK first in 2023 and was this summer recommended by NICE, the body responsible for negotiating agreements with pharmaceutical companies in respect of reimbursement for use on the NHS in England. He commented that the approval of ATMPs is of increasing relevance, pointing to data publicised by the Association of the British Pharmaceutical Industry (ABPI) in August in which the trade body highlighted that the MHRA had approved just two ATMPs per year on average over the past five years but how that rate is projected to increase up to between 10 and 15 per year by 2030.

POC products will be eligible to benefit from the innovative licensing and access pathway (ILAP) that the MHRA operates. ILAP was introduced post-Brexit to accelerate the time it takes to bring products, including ATMPs, to market and thereby facilitate patient access to innovative new medicines.

Alongside the new POC manufacturing regulations, the MHRA has also laid new regulations to provide for a new post-market surveillance regime for medical devices regulated in the UK. Those regulations are also expected to take effect in the summer of 2025.